None listed
Conditions
Brief summary
The purpose of this study is to assess the use of a 3D-printed scaffold, which is designed and tailored for each person, for the purpose of re-growing jaw bone. This may allow a more appropriate bone height for placement of dental implants, and could assist in making the future plate/denture fit better and be easier to clean. Who is it for? You may be eligible to join this study if you are aged between 18 years and 60 years old; have had head/neck ablation and reconstruction surgery within the previous 6-24 months; have a discrepancy between the old and new jaw bone; and have NOT undergone any radiation treatment previously. Study details Participating in this study involves having an operation to place the 3D printed scaffold under a general anaesthetic, which is likely a 2-3 hour procedure. The reconstruction plate used to heal your mandible after your initial tumour removal surgery will be removed at the same time. A small amount (2-3mls) of bone will be taken from your hip, and cells from your blood will be taken and placed in the scaffold to encourage bone formation. This operation will need an overnight stay to make sure you are healing well before going home. Once the scaffold is in place, a repeat CT scan will be performed 9 months after scaffold insertion to measure the amount of extra bone formation. Another 1-2 hour operation will then be performed to place dental implants, which is the next key step in getting teeth after your tumour surgery. This procedure is a day surgery procedure, so you will be going home on the same day. You will be asked to fill out surveys at various stages of the treatment to help us determine the best way to provide this care for future patients. It is hoped that this study will show that using this tailored, 3D-printed scaffold can help regenerate bone in the jaw; and thus improve dental rehabilitation outcomes for patients who have had ablation and reconstruction surgery.
Interventions
This study is an open label, single-arm feasibility trial study of dental implants to be run at Metro North Health through the Oral and Maxillofacial Surgery unit at the Royal Brisbane and Women’s Hospital (RBWH), with collaboration from the supporting department Herston Biofabrication Institute. The mPCL-TCP scaffold implants and are manufactured by Osteopore (Singapore). Osteopore has implants made from the same material listed on the ARTG (eg ARTG ID 334287).
Use of participant specific medi
This study is an open label, single-arm feasibility trial study of dental implants to be run at Metro North Health through the Oral and Maxillofacial Surgery unit at the Royal Brisbane and Women’s Hospital (RBWH), with collaboration from the supporting department Herston Biofabrication Institute. The mPCL-TCP scaffold implants and are manufactured by Osteopore (Singapore). Osteopore has implants made from the same material listed on the ARTG (eg ARTG ID 334287). Use of participant specific medical grade polycaprolactone and tricalcium phosphate (mPCL-TCP) scaffolds in conjunction with autologous bone chips, injectable platelet rich fibrin (i-PRF) and cancellous bone aspirate (CBA) for vertical augmentation of the neo-mandible for participants who have undergone ablative surgery and reconstruction to the mandible with either a fibula free flap reconstruction, or a marginal mandibulectomy. Participants will be recruited from patients already treated by the Oral and Maxillofacial Surgery Unit who are being reviewed regularly for surveillance of their pathology. Pre-implantation of the scaffold, all participants will undergo a fine slice of CT facial bones, that is anticipated to take around 15-20 minutes, for scaffold design. Participant specific mPCL-TCP scaffold outlines will be designed from participant CT data by biomedical engineers at the Herston Biofabrication Institute with iterative input from the treating clinicians from the RBWH Oral and Maxillofacial Surgery unit. The scaffold will then be manufactured by Osteopore (Singapore). Surgical placement of the scaffold will be performed under a general anaesthetic at the RBWH by Oral and Maxillofacial consultants at the same time as removal of the reconstruction plate. Surgery typically takes around 3-4 hours and involves making a neck incision through the previous scar, removing the reconstruction plate, preparing the site for scaffold implantation and implanting the mPCL-TCP scaffold. Thereafter, autologous bone graft particles collected during the scaffold placement preparation and i-PRF and cancellous bone aspirate will be injected in the scaffold. Autologous bone graft will be collected from the iliac crest. The quantity depends on the size of the scaffold, but is estimated to be 2-3mls of compressed bone. Nine months after scaffold placement, a repeat CT will be performed to evaluate the amount of bone formed within the scaffold. A subsequent procedure involving placement of standard Neoss dental implants (as is standard of care for patients who have undergone ablative surgery and reconstruction to the mandible with either a fibula free flap reconstruction, or a marginal mandibulectomy) will be performed to facilitate complete dental rehabilitation. At the time of preparation of the dental implant osteotomy, a core of bone will be taken for histopathologic analysis for the study.
Sponsors
Metro North Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• Patients under surveillance after head and neck ablation and reconstruction – within 6- 24 months post-surgery • Patients interested in oral/dental rehabilitation • Significant vertical bony height discrepancy (Minimum of 6mm height discrepancy between native mandible and level of resected/neomandible) • Not previously irradiated • Adequate soft tissue to cover scaffold • Women of reproductive age who are currently on one of the following methods of contraception: - Barrier method of contraception: condoms (male or female) with or without spermicidal agent, diaphragm, or cervical cap with spermicide - Intrauterine device - Hormone-based contraceptive • Participant willing and able to comply with the study requirements • Participant or guardian capable of providing valid informed consent
Exclusion criteria
• Irradiated patients • Current smokers • Poorly controlled diabetics (HbA1c of >7%) • Patient or guardian unwilling or unable to provide fully informed consent. • Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy, or other cause for secondary/primary immunodeficiency. • Known severe concurrent or inter-current illness including: cardiovascular, respiratory, or immunological illness, psychiatric disorders, or alcohol or chemical dependence, or possible allergies (including allergy to PCL) that, at the discretion of the clinical leads Dr Omar Breik and A/Prof Martin Batstone, would compromise the participant safety or compliance or interfere with interpretation of study results. • Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the reconstruction surgery. • Women of childbearing potential without an appropriate contraceptive method. • Life expectancy less than 24 months. • Unable or unwilling to comply with the study requirements. • Patients unlikely to proceed to dental rehabilitation (These are usually patient who are not interested in undergoing multiple procedures for rehabilitation, patients who have multiple failed appointments, poor oral hygiene, or advanced dental disease affecting their remaining teeth such as periodontitis or dental caries.) • Unreliable follow up record (Multiple failed attendances for their regular follow up appointments)
Outcome results
None listed